Changes in Natural Immunity in Pregnant Women With Autoimmune Thyroid Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Rijeka
About this trial
Autoimmune thyroid disease (AITD) is the most common endocrine disorder in women of reproductive age, including during pregnancy. It encompasses two clinical conditions: autoimmune hyperthyroidism and hypothyroidism. Pregnancy significantly affects thyroid function regulation, while thyroid dysfunction can influence fertility, pregnancy progression, and the postpartum health. Although the role of acquired immunity in AITD is well understood, recent research increasingly emphasizes innate immunity. Key cells involved in innate immunity include neutrophils, monocytes, and NKT cells. However, limited data exist on their role during pregnancy, especially in women with AITD.
This study aims to investigate the dynamic changes in neutrophils, monocytes and NKT cells during pregnancy and compare findings between women with normal pregnancies and those with AITD.
The study will analyze the frequency and activation status of these innate immune cells in peripheral blood samples collected during the first, second, and third trimesters. In addition, concentrations of thyrotropin, thyroid hormones, thyroglobulin, and thyroid autoantibodies, will be measured. A thyroid ultrasound will also be performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
with a single pregnancy
older than 18 years
who have signed the informed consent form
Disqualifiers
pregnant women who refuse to give informed consent
pregnant women under the age of 18
pregnant women with malignant diseases
pregnant women with thyrotoxicosis or hypothyroidism of a non-autoimmune nature and previous thyroidectomy or ablative therapy with iodine-131
Trial population
The planned prospective observational study will include pregnant women referred by primary care clinics in Rijeka and Primorsko-goranska County to the Clinical Department of Nuclear Medicine and the Department of Endocrinology, Diabetes and Metabolic Diseases of the Clinic of Internal Medicine of the Clinical Hospital Center Rijeka for thyroid examination and who have signed an informed consent form.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Pregnant women referred for thyroid examination due to suspected thyroid disease
Trial outcomes
Primary outcomes
1
Frequency of Neutrophils in Peripheral Blood
Frequency of neutrophils will be measured by differential blood count. Unit of Measure: Percent (%)
Time frame
Within 24 months from enrollment; analysis over a 12-month period.2
Frequency of Monocytes in Peripheral Blood
Monocyte frequency will be measured by flow cytometry and expressed as percentage of monocytes among CD45⁺ leukocytes. Unit of Measure: Percent (%)
Time frame
Within 24 months from enrollment; analysis over a 12-month period.3
Frequency of NKT Cells in Peripheral Blood
NKT cell frequency will be measured by flow cytometry and expressed as percentage of NKT cells within CD3⁺ T lymphocytes. Unit of Measure: Percent (%)
Time frame
Within 24 months from enrollment; analysis over a 12-month period.Secondary outcomes
1
Expression of HLA-DR on Monocytes
HLA-DR expression on CD14⁺ monocytes will be measured using flow cytometry and expressed as percentage of HLA-DR⁺ monocytes. Unit of Measure: Percent (%)
Time frame
Within 24 months from enrollment.2
Expression of CD25 on NKT Cells
CD25 expression on CD3⁺CD56⁺ NKT cells will be measured using flow cytometry and expressed as percentage of CD25⁺ cells. Unit of Measure: Percent (%)
Time frame
Within 24 months from enrollment.3
Expression of CD69 on NKT Cells
CD69 expression on CD3⁺CD56⁺ NKT cells will be measured using flow cytometry and expressed as percentage of CD69⁺ cells. Unit of Measure: Percent (%)
Time frame
Time Frame: Within 24 months from enrollment.4
Serum Concentration of TSH
TSH concentration will be measured using a chemiluminescent immunoassay (CLIA). Unit of Measure: mU/L
Time frame
Measured at each trimester; analysis completed within 12 months of final collection.Other outcomes
1
Correlation Between Immune Cell Frequencies and Thyroid Biomarkers
Correlation between neutrophil, monocyte, and NKT cell frequencies and thyroid hormone/antibody levels. Unit of Measure: Correlation coefficient (r)
Time frame
Within 24 months from enrollment.2
Correlation Between Activation Marker Expression and Thyroid Biomarkers
Correlation between expression of HLA-DR, CD25, and CD69 and thyroid hormone/antibody levels. Unit of Measure: Correlation coefficient (r)
Time frame
Within 24 months from enrollment.3
Gestational Age at Delivery
Unit of Measure: Weeks
Time frame
Time Frame: At delivery4
Birth Weight
Unit of Measure: Grams
Time frame
Time Frame: At deliverySponsors and contacts
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Source ClinicalTrials.gov
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